China NMPA Newsletter – December 2023


China NMPA Newsletter

Featured Articles

NMPA New Approvals in November 2023

In November 2023, NMPA approved 301 medical devices, including 34 Class III imported products, 39 Class II imported products, and 226 Class III domestic products.

Below is a list of approved Class III and Class II imported products in November 2023.

Medical Device/IVD Manufacturer Category
Proton Therapy System Varian Medical Systems Particle Therapy GmbH & Co. KG Class III
Amplatzer Talisman PFO Occluder Abbott Medical Class III
Amplatzer Talisman Delivery Sheath Abbott Medical Class III
CONTACT LENSES Supervision Optimax Sdn Bhd Class III
Arctic Sperm Cryopreservation Medium FUJIFILM Irvine Scientific, Inc. Class III
Anchored balloon dilatation catheter 株式会社カネカ Class III
Dual-curing bonding resin watermend Tokuyama Dental Corporation Class III
SU-POR Patient-Specific Surgical Implant Poriferous, LLC Class III
Sterile Silicone Breast Implants Motiva Implant Matrix Establishment Labs S.A. Class III
ProTi360°Interbody System Tyber Medical, LLC Class III
MP Monoblock Hip Prosthesis Stem Waldemar Link GmbH & Co. KG Class III

NMPA Upgrades Regulatory Classification of Degradable Expandable Hemostatic Sponge Products

NMPA released information on December 4th to upgrade the classification of Degradable Expandable Hemostatic Sponge Products from Class II to Class III. In an effort to clarify the management attributes and categories of Degradable Expandable Hemostatic Sponge products, the National Medical Products Administration has released a notice outlining key considerations. The following details are now officially communicated:


China and Denmark Strengthen Comprehensive Strategic Partnership with “Green Joint Action Plan”

Background:Recognizing the mutual benefits of collaboration on bilateral, multilateral, and global issues, the People’s Republic of China and the Kingdom of Denmark established a comprehensive strategic partnership in 2008. Underlining their commitment, both nations formulated the “China-Denmark Joint Action Plan (2017-2020)” in 2017. In November 2021, the foreign ministers of China and Denmark agreed on the “China-Denmark Green Joint Action Plan,” further solidifying bilateral cooperation within the framework of their comprehensive strategic partnership.


China NMPA Reports 6 Cases of Illegal Online Sales of Medical Devices

On December 5th , the National Medical Products Administration (NMPA) has guided local drug regulatory authorities to intensify monitoring and crack down on illegal activities through the National Medical Device Online Sales Monitoring Platform. This initiative aims to protect public health and ensure the safety of medical equipment.

Featured News-Medical Aesthetics

China National Medical Products Administration Clarifies Management Category for Biodegradable Hemostatic Sponges

On December 6, 2023, China National Medical Products Administration’s Comprehensive Department outlined the categorization of Biodegradable Hemostatic Sponges, specifying a shift from Class II to Class III in the management hierarchy.


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